Regulatory Affairs Director, Oncology

Are you a strategically focused Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! 

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. 

Within Oncology Regulatory Science and Strategy (ORSS) we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. 

The RAD provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management of the assigned product(s). The RAD serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs, or as regional regulatory lead. Contributes significantly to overall product and clinical strategy. The role plays a key role influencing Regulatory authorities through regular contacts to improve Regulatory outcomes. The RAD leads cross- functional Teams in major Regulatory Submissions (NDA, IND/CTA), Health Authority Interactions, Label discussions, and securing NDA/BLA Approvals. As a GRL the RAD leads the Global Regulatory Strategy Team (GRST) in formulating Global Regulatory strategy and delivering on NDA Filings and Approvals. Alternatively, as a regional regulatory lead, the RAD is a member of the GRST and is accountable for providing the region-specific Regulatory strategy and advice. The RAD serves as the face of the company with Health Authorities.

What you’ll do 

• Accountable for leading the development and implementation of the regional or global regulatory strategy for a product/group of products. Ensures that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. This includes health authority engagement strategy and considerations of expedited regulatory programs.
• Lead cross-functional Teams in major health authority interactions. This includes setting the strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself.
• Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Participate in coaching, and performance feedback to members of your GRST.
• May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and be accountable for all Regulatory activities
• Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. Lead preparation of the regulatory strategy document and target product labeling.
• Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and participate in coaching, and performance feedback to members of the GRST.
• Accountable for initiating and delivering key regulatory documents and plans and leading the negotiations with health authorities.
• Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
• Ensures appropriate planning and construction of the global dossier and core prescribing information led by the respective teams.  Accountable for product maintenance, supply and compliance activities associated with marketed brands.
• Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

Minimum Qualifications:

• Bachelor's degree in a science related field or other appropriate knowledge/experience
• At least 5-year experience of regulatory drug development or equivalent, and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and labeling negotiations would be a plus.
• A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.
• Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
• The ability to think strategically and critically and evaluate risks to regulatory activities.

Desirable Qualifications: 

• Experience in Oncology (small molecules & biologics) is preferred.
• Prior experience with phase 3 design including end of phase 2 health authority interactions.
• Contribution to a regulatory approval including leading response team and labelling negotiation.
• Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design 
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs 
• Ability to work strategically within a business critical and high-profile development program 
• Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component. 

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next? 

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

The annual base pay (or hourly rate of compensation) for this position ranges from $186,232.80 - $279,349 USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.